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Informed Consent

Informed consent is an important aspect of any genetic test or research study. The NHGRI has participated in policy development in the area of informed consent as it relates to genetic/genomic studies. Because of the often profound impact of genetic testing, patients should be adequately counseled about the specifics of that test.

Before an individual agrees to participate in a clinical trial, research project or undergo a genetic test, he or she must be informed of the test's purpose, medical implications, alternatives, and possible risks and benefits. Patients should additionally be made aware of their privacy rights, including where their DNA will be stored and who will have access to their personal information.

An informed consent document, requiring the patient's signature, should articulate all of these details. Even after signing, the patient may still opt out of the test or study; the informed consent document is not a contract.

Federal Policy

Federal Legislation

Below is a list of bills that were introduced or passed in the 108th Congress (2003 -2004) regarding informed consent. Many bills contain language that addresses both discrimination and privacy and therefore will be listed in multiple categories.

108th Congress
  • H.R.3594 IH (Introduced in House): Protection for Participants in Research Act of 2003
  • H.R.4531 IH: Ronald Reagan Memorial Stem Cell Research Act of 2004
  • S.2083 IS (Introduced in Senate): Bipartisan Patient Protection Act of 2004
  • S.1945 IS (Introduced in Senate): Bipartisan Patient Protection Act

Informed Consent Federal Legislation Archive




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Last Updated: March 11, 2014

See Also:

ELSI Research Program